Metoclopramide

Product NDC: 17856-1190
11-digit product format: 178561190
Labeler code: 17856
Product ID: 17856-1190_3ce771f8-a078-c4ca-e063-6294a90ae2b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA071402
Marketing category: ANDA
Marketing start: 2015-05-18
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1993-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A071402-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071402-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071402-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071402-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071402-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071402-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071402-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071402-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071402-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071402-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071402-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071402-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071402-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071402-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071402-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071402-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071402-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071402-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071402-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071402-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071402-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071402-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071402-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071402-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071402-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071402-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071402-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071402-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071402-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071402-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071402-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071402-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071402-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071402-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071402-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071402-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071402-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071402-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071402-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071402-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071402-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metoclopramide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOCLOPRAMIDE HYDROCHLORIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W1792A2RVD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104884	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ce3245f-7021-5135-e063-6394a90a7d95	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
86441fd8-22b8-41db-bb26-c70dffc3923b	Product name	1	20210111
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
340a6817-217a-4b71-9e83-8e2e60c4b0c5	Product name	1	20150319
1f2c49ec-0a44-8021-ecde-b27ece080b13	Product name	1	20140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-1190-1	Metoclopramide	72 in 1 CASE	SOLUTION	72	2
17856-1190-1	Metoclopramide	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	2
17856-1190-2	Metoclopramide	1 mL in 1 SYRINGE	SOLUTION	1	2
17856-1190-2	Metoclopramide	120 in 1 CASE	SOLUTION	120	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE	American Health Packaging	0034a97a-fb05-418a-a234-de278907cd2a	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	84ec68c1-efa0-4ed2-9fae-d0cc17b0a6b4	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	ATLANTIC BIOLOGICALS CORP.	3ce3245f-7021-5135-e063-6394a90a7d95	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402 ndc (product): 17856-1190
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	67024bbc-65d1-428d-a807-46647038daf6	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	14114420-fee0-4850-b99e-cdb5f421cd33	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	e34fea34-5fc5-4200-bc9d-f5e558023630	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	ANI Pharmaceuticals, Inc.	4e12e98a-06fe-4b3c-bb64-f2701e195c74	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	9530014b-c266-4015-9195-9f100d67317b	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W1792A2RVD	METOCLOPRAMIDE HYDROCHLORIDE	54143-57-6	METOCLOPRAMIDE HYDROCHLORIDE
L4YEB44I46	METOCLOPRAMIDE	364-62-5	Metoclopramide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	3ce3245f-7021-5135-e063-6394a90a7d95	2
104884	metoclopramide 1 MG/ML Oral Solution	SCD	3ce3245f-7021-5135-e063-6394a90a7d95	2
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	3ce3245f-7021-5135-e063-6394a90a7d95	2
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	3ce3245f-7021-5135-e063-6394a90a7d95	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
17856-1190-1	17856119001	72 CUP, UNIT-DOSE in 1 CASE (17856-1190-1) / 5 mL in 1 CUP, UNIT-DOSE		2025-08-21	No	No	Current
17856-1190-2	17856119002	120 SYRINGE in 1 CASE (17856-1190-2) / 1 mL in 1 SYRINGE	120 syringe	2025-08-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	ATLANTIC BIOLOGICALS CORP.	2025-08-21	HUMAN PRESCRIPTION DRUG LABEL	2